Medtronic, Inc. presented 7-year clinical and radiographic outcomes of artificial disc replacement with PRESTIGE® Cervical Disc compared to anterior cervical discectomy and fusion (ACDF) at the Cervical Spine Research Society Annual Meeting held in Los Angeles, CA last week.
Background
Medtronic’s PRESTIGE® Cervical Disc is a stainless steel device and articulates via a ball and trough mechanism. It was the first artificial cervical disc FDA-approved for the treatment of single-level cervical disc disease (radiculopathy and/or myelopathy).
The 7-year data presented at the Cervical Spine Research Society meeting followed up 395 patients of the 541 patients enrolled in the study. 212 PRESTIGE® Disc and 183 fusion patients completed seven years of clinical follow-up. Results indicate that significant improvements in pain and functional outcomes achieved by 1.5 months in both groups were sustained at seven years.
Specific findings at seven years included an overall success rate that was significantly higher (p = 0.010) in the PRESTIGE® Disc group (72.6%) as compared to fusion (60.0%). The rate of maintenance or improvement in neurological status was significantly higher (p = 0.011) compared to fusion (88.2% versus 79.7%). Neck pain was significantly lower (p = 0.004) compared to fusion (mean score of 13.1 versus 19.4 on a scale of 0-100). The rate of additional surgeries at the index level was significantly lower (p < 0.001, log-rank test from a Kaplan-Meier analysis) compared to fusion (4.8% versus 13.7%). At seven years, one incident of screw loosening in the investigational group classified as associated with implant/surgical procedure was observed.
Physician comments
“In the past several years, the long-term implications of cervical disc replacement have been the subject of much debate,” said Dr. Vincent Traynelis, director, Neurosurgery Spine Service, and vice chairperson and professor, Department of Neurosurgery, at Rush University Medical Center in Chicago, IL. “The 7-year results of this study show that patients receiving cervical disc replacement maintained their clinical improvements and had a significantly lower rate of additional surgical procedures compared to fusion.”
Company comments
“We are pleased to be the first company to offer 7-year level-one clinical evidence on cervical disc replacement,” said Patrick Wilson, vice president, Global Cervical Spine Therapies of Medtronic’s Spinal business, “both physicians and patients will benefit from access to this information when making decisions about the PRESTIGE® Disc.”
published: December 9, 2013 in: Clinical Studies/Trials, Congresses and Meetings, Medtronic, Spine